Study identifier:D4880C00010
ClinicalTrials.gov identifier:NCT02141347
EudraCT identifier:N/A
CTIS identifier:N/A
A Ph1 Open-Label Multicentre Study to Assess Safety, Tolerability, PK and Anti-tumor Activity of Tremelimumab /Tremelimumab with MEDI4736 in Japanese with Advanced Solid Malignancies or Tremelimumab in Japanese with Malignant Mesothelioma
Part A and B: advanced solid malignancies
Phase 1
No
Tremelimumab, MEDI4736
All
65
Interventional
20 Years - 130 Years
Allocation: Non-randomized
Endpoint Classification: Safety
Intervention Model: -
Masking: Open Label
Primary Purpose: Other
Verified 01 Dec 2018 by AstraZeneca
AstraZeneca
-
A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, PK and Preliminary Anti-tumor Activity when given as a monotherapy of Tremelimumab or Tremelimumab in combination with MEDI4736 in Japanese Patients with Advanced Solid Malignancies, and when given as a monotherapy of tremelimumab in Second- or Third-line Treatment of Japanese Subjects with Unresectable Pleural or Peritoneal Malignant Mesothelioma
Primary objectives Part A: To investigate the safety and tolerability of tremelimumab when given to Japanese patients with advanced solid malignancies and define the dose(s) for further clinical evaluation. Part B: To investigate the safety and tolerability of tremelimumab in combination with MEDI4736 when given to Japanese patients with advanced solid malignancies and to define the dose(s) for further clinical evaluation. Part C: To investigate the safety and tolerability of tremelimumab when given to Japanese patients with unresectable pleural or peritoneal malignant mesothelioma.
Location
Location
Sapporo-shi, Japan, 003-0804
Location
Chuo-ku, Japan, 104-0045
Location
Bunkyo-ku, Japan, 113-8431
Location
Yokohama-shi, Japan, 236-0051
Location
Sunto-gun, Japan, 411-8777
Location
Nagoya-shi, Japan, 464-8681
Location
Osaka-shi, Japan, 541-8567
Location
Nishinomiya-shi, Japan, 663-8501
Arms | Assigned Interventions |
---|---|
Other: Part A Dose escalation of tremelimumab mono therapy for advanced solid malignancies | Drug: Tremelimumab Tremelimumab administered intravenously |
Other: Part B Combination therapy of tremelimumab and MEDI4736 for advanced solid malignancies | Drug: Tremelimumab Tremelimumab administered intravenously Drug: MEDI4736 MEDI4736 administered intravenously. |
Other: Part C Fixed dose of tremelimumab for malignant mesothelioma | Drug: Tremelimumab Tremelimumab administered intravenously |
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